Uses

This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that may include the removal of unattached, infected nails by a health care professional. Ciclopirox works by stopping the growth of fungus.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using ciclopirox and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before starting treatment, remove any loose nail material using nail clippers or a file. If you have diabetes or numbness in your fingers/toes, talk to your doctor before filing or trimming your nails. It may be safer for your doctor to file or remove your nails.

Use this medication on the nails and skin next to the nails only. Apply ciclopirox as directed by your doctor, usually once daily at bedtime. Using the applicator provided, apply this medication evenly over the entire affected nail and to the area of the skin next to the nail (5 millimeters or 1/5 of an inch around the nail). If the applicator can reach the undersurface of the nail and the skin under the nail, apply the medication to those areas as well. Avoid contact with skin that is not right next to the affected nail. Do not use nail cosmetic products (such as nail polish) on the treated nails.

Do not apply the medication in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, rinse with plenty of water.

Let the medication dry (around 30 seconds) before putting on socks or stockings. Do not wash the treated area for at least 8 hours.

Every 7 days, remove the medication from the nail by applying alcohol. Then trim the nail and file away any loose nail material.

Since this product is flammable, do not use this product near heat or open flame.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Continue to use this medication for the full time prescribed, even if symptoms disappear. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition worsens or does not improve after 6 months of treatment. It may take up to one year for the nail to be clear or almost clear.

Side Effects

Redness/burning of treated skin or changes in shape/color of nail may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• blistering/swelling/oozing at the application site

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using ciclopirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• numbness in fingers/toes (such as diabetic neuropathy)

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light, heat, or open flame. To protect the medication from light, store the bottle in the carton after each use. Keep bottle tightly closed. To prevent the cap from sticking to the bottle, avoid getting the medication on the bottle threads. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.